Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire, Computed Tomography, MSCT
Brief summary
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)
Interventions
DRUGAZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
DRUGPlacebo
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD with symptoms over 1 year * FEV1/FVC \< 70% and FEV1 \>= 40 and \< =70 % of predicted post-bronchodilator * Ex-smokers for at least 12 months
Exclusion criteria
* Past history or current evidence of clinically significant heart disease * Current diagnosis of asthma * Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm) | Measured after 12 weeks treatment (day 84) | AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Air Trapping Index (ATI) on Expiratory Scans | Measured after 12 weeks treatment (day 84) | ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean. |
| Pre-bronchodilator Inspiratory Capacity (IC) | Measured after 12 weeks treatment (day 84) | Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. |
| Pre-bronchodilator Total Lung Capacity (TLC) | Measured after 12 weeks treatment (day 84) | Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. |
| Pre-bronchodilator Functional Residual Capacity (FRC) | Measured after 12 weeks treatment (day 84) | Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. |
| Pre-bronchodilator Residual Volume (RV) | Measured after 12 weeks treatment (day 84) | Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean. |
| Pre-bronchodilator Specific Airway Conductance (SGaw) | Measured after 12 weeks treatment (day 84) | Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean. |
| Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) | Measured after 12 weeks treatment (day 84) | Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean. |
| Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Measured after 12 weeks treatment (day 84) | Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF). |
| Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Measured after 12 weeks treatment (day 84) | Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF). |
| Pre-bronchodilator Forced Vital Capacity (FVC) | Measured after 12 weeks treatment (day 84) | Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF). |
| Post-bronchodilator Forced Vital Capacity (FVC) | Measured after 12 weeks treatment (day 84) | Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF). |
| 5th Generation Wall Area Percentage | Measured after 12 weeks treatment (day 84) | 5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean. |
| Post-bronchodilator Slow Vital Capacity (SVC) | Measured after 12 weeks treatment (day 84) | Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF). |
| Peak Expiratory Flow (PEF) Morning (Daily Recordings) | Average from measurements recorded daily by patient in last 6 weeks of treatment. | Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. |
| Peak Expiratory Flow (PEF) Evening (Daily Recordings) | Average from measurements recorded daily by patient in last 6 weeks of treatment. | Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening . |
| Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings) | Average from measurements recorded daily by patient in last 6 weeks of treatment. | Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. |
| Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings) | Average from measurements recorded daily by patient in last 6 weeks of treatment. | Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening. |
| Breathlessness, Cough and Sputum Scale (BCSS) Total Score | Average from measurements recorded daily by patient in last 6 weeks of treatment. | Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). |
| EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score | Average from measurements recorded daily by patient in last 6 weeks of treatment. | EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). |
| St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score | Measured after 12 weeks treatment (day 84) | St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)). |
| Percentage of Reliever Free Days in Last Six Weeks of Treatment | Average from measurements recorded daily by patient in last 6 weeks of treatment. | Percentage of reliever free days in last 6 weeks on treatment. |
| Exacerbations | Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up) | Number of patients experiencing disease exacerbations on treatment. |
| Pre-bronchodilator Slow Vital Capacity (SVC) | Measured after 12 weeks treatment (day 84) | Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF). |
Countries
Canada, Denmark, Netherlands, Romania, Ukraine
Participant flow
Recruitment details
First patient enrolled: 06 January 2010; Last patient completed: 17 November 2010; Twelve centres across 5 countries participated in this study: Canada (2), Denmark (3), The Netherlands (2), Romania (2) and Ukraine (3).
Pre-assignment details
Tiotropium maintenance therapy and reliever medication were commenced at screening, except for patients on inhaled corticosteroids (ICS, ICS/LABA) who were required to stop these at enrolment and commence on tiotropium and reliever medication at the same time. These patients received tiotropium for a period of at least 3 weeks before screening.
Participants by arm
| Arm | Count |
|---|---|
| AZD9668 AZD9668 2x30mg bid | 25 |
| Placebo Placebo 2 tablets bid | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | AZD9668 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 7.2 years STANDARD_DEVIATION 65 | 7.7 years STANDARD_DEVIATION 66 | 7.45 years STANDARD_DEVIATION 131 |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 25 | 8 / 27 |
| serious Total, serious adverse events | 0 / 25 | 1 / 27 |
Outcome results
Primary
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm) | 3.84 mm | Standard Error 0.021 |
| Placebo | AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm) | 3.83 mm | Standard Error 0.017 |
Secondary
5th Generation Wall Area Percentage
5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | 5th Generation Wall Area Percentage | 66.21 Percentage Area | Standard Error 0.275 |
| Placebo | 5th Generation Wall Area Percentage | 65.94 Percentage Area | Standard Error 0.234 |
Secondary
Air Trapping Index (ATI) on Expiratory Scans
ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Air Trapping Index (ATI) on Expiratory Scans | 54.56 ATI Percentage | Standard Error 1.706 |
| Placebo | Air Trapping Index (ATI) on Expiratory Scans | 57.12 ATI Percentage | Standard Error 1.599 |
Secondary
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Breathlessness, Cough and Sputum Scale (BCSS) Total Score | 2.33 Total Score | Standard Error 0.319 |
| Placebo | Breathlessness, Cough and Sputum Scale (BCSS) Total Score | 3.36 Total Score | Standard Error 0.301 |
Secondary
Exacerbations
Number of patients experiencing disease exacerbations on treatment.
Time frame: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD9668 | Exacerbations | 0 Participants |
| Placebo | Exacerbations | 5 Participants |
Secondary
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score | 28.48 Total Score | Standard Error 2.065 |
| Placebo | EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score | 33.26 Total Score | Standard Error 2.013 |
Secondary
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings) | 1.51 L | Standard Error 0.062 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings) | 1.30 L | Standard Error 0.064 |
Secondary
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings) | 1.49 L | Standard Error 0.065 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings) | 1.29 L | Standard Error 0.066 |
Secondary
Peak Expiratory Flow (PEF) Evening (Daily Recordings)
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Peak Expiratory Flow (PEF) Evening (Daily Recordings) | 264.15 L/min | Standard Error 10.02 |
| Placebo | Peak Expiratory Flow (PEF) Evening (Daily Recordings) | 254.31 L/min | Standard Error 9.966 |
Secondary
Peak Expiratory Flow (PEF) Morning (Daily Recordings)
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Peak Expiratory Flow (PEF) Morning (Daily Recordings) | 255.82 L/min | Standard Error 9.956 |
| Placebo | Peak Expiratory Flow (PEF) Morning (Daily Recordings) | 244.16 L/min | Standard Error 9.871 |
Secondary
Percentage of Reliever Free Days in Last Six Weeks of Treatment
Percentage of reliever free days in last 6 weeks on treatment.
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Percentage of Reliever Free Days in Last Six Weeks of Treatment | 34.23 percentage of days | Standard Error 6.394 |
| Placebo | Percentage of Reliever Free Days in Last Six Weeks of Treatment | 26.43 percentage of days | Standard Error 6.001 |
Secondary
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | 1.60 L | Standard Error 0.05 |
| Placebo | Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | 1.58 L | Standard Error 0.05 |
Secondary
Post-bronchodilator Forced Vital Capacity (FVC)
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Post-bronchodilator Forced Vital Capacity (FVC) | 3.34 L | Standard Error 0.083 |
| Placebo | Post-bronchodilator Forced Vital Capacity (FVC) | 3.34 L | Standard Error 0.08 |
Secondary
Post-bronchodilator Slow Vital Capacity (SVC)
Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Post-bronchodilator Slow Vital Capacity (SVC) | 3.56 L | Standard Error 0.063 |
| Placebo | Post-bronchodilator Slow Vital Capacity (SVC) | 3.44 L | Standard Error 0.061 |
Secondary
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) | 5.49 mmol/kPa*min | Standard Error 0.204 |
| Placebo | Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) | 5.67 mmol/kPa*min | Standard Error 0.209 |
Secondary
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | 1.51 L | Standard Error 0.048 |
| Placebo | Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | 1.49 L | Standard Error 0.05 |
Secondary
Pre-bronchodilator Forced Vital Capacity (FVC)
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Forced Vital Capacity (FVC) | 3.25 L | Standard Error 0.084 |
| Placebo | Pre-bronchodilator Forced Vital Capacity (FVC) | 3.14 L | Standard Error 0.083 |
Secondary
Pre-bronchodilator Functional Residual Capacity (FRC)
Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Functional Residual Capacity (FRC) | 4.41 L | Standard Error 0.165 |
| Placebo | Pre-bronchodilator Functional Residual Capacity (FRC) | 4.21 L | Standard Error 0.158 |
Secondary
Pre-bronchodilator Inspiratory Capacity (IC)
Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Inspiratory Capacity (IC) | 2.56 L | Standard Error 0.154 |
| Placebo | Pre-bronchodilator Inspiratory Capacity (IC) | 2.39 L | Standard Error 0.153 |
Secondary
Pre-bronchodilator Residual Volume (RV)
Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Residual Volume (RV) | 3.64 L | Standard Error 0.161 |
| Placebo | Pre-bronchodilator Residual Volume (RV) | 3.73 L | Standard Error 0.161 |
Secondary
Pre-bronchodilator Slow Vital Capacity (SVC)
Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Slow Vital Capacity (SVC) | 3.42 L | Standard Error 0.069 |
| Placebo | Pre-bronchodilator Slow Vital Capacity (SVC) | 3.38 L | Standard Error 0.068 |
Secondary
Pre-bronchodilator Specific Airway Conductance (SGaw)
Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Specific Airway Conductance (SGaw) | 0.52 1/[s*kPa] | Standard Error 0.034 |
| Placebo | Pre-bronchodilator Specific Airway Conductance (SGaw) | 0.48 1/[s*kPa] | Standard Error 0.034 |
Secondary
Pre-bronchodilator Total Lung Capacity (TLC)
Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | Pre-bronchodilator Total Lung Capacity (TLC) | 7.03 L | Standard Error 0.178 |
| Placebo | Pre-bronchodilator Total Lung Capacity (TLC) | 6.92 L | Standard Error 0.177 |
Secondary
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
Time frame: Measured after 12 weeks treatment (day 84)
Population: The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD9668 | St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score | 35.64 Scores on a scale | Standard Error 2.364 |
| Placebo | St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score | 39.61 Scores on a scale | Standard Error 2.389 |